Prescription Drugs and the Duty to Warn: An Argument for

Cleveland State Law Review Cleveland State Law Review

Volume 39 Issue 1 Article 7

1991

Prescription Drugs and the Duty to Warn: An Argument for Patient Prescription Drugs and the Duty to Warn: An Argument for Patient

Package Inserts Package Inserts

Alan R. Styles

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Recommended Citation Recommended Citation Note, Prescription Drugs and the Duty to Warn: An Argument for Patient Package Inserts, 39 Clev. St. L. Rev. 111 (1991)

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PRESCRIPTION DRUGS AND THE DUTY TO WARN:AN ARGUMENT FOR PATIENT PACKAGE INSERTS

I. INTRODUCTION .................................................. 112II. PATIENT INFORMATION ......................................... 112

A . Introduction ................................................. 112B. Informed Consent ........................................... 113

1. Balancing the Risks and Benefits ..................... 1132. Elective and Non-Elective Drugs ..................... 114

C. Ensuring Safety and Efficacy .............................. 1151. Patient Instruction ..................................... 116

a. Patient Compliance .................................. 116b. Drug Interactions .................................... 116

2. Patient Warnings ....................................... 117a. Recognition of Adverse Reactions ............. 117b. Patient Compliance .................................. 118

D. Advantages of Written Information ....................... 118III. PRESCRIPTION DRUGS AND THE DUTY TO WARN ............. 119

A. The Manufacturer's Duty to Warn and the LearnedIntermediary Doctrine ...................................... 1191. Rationale of the Doctrine .............................. 1202. Development of the Doctrine .......................... 1213. Decline of the Doctrine ................................. 1234. The Mass Immunization Exception ................... 1245. The Oral Contraceptive Exception .................... 125

B. The Physician's Duty to Warn and the InformedConsent Doctrine ............................................ 1271. Rationale of the Doctrine .............................. 1272. Scope of the Duty to Warn ............................. 1283. The Doctrine and the Prescription Drugs ............ 129

IV. FDA REGULATION OF PATIENT INFORMATION ................ 131A . Introduction ................................................. 131B. Patient Warnings ........................................... 131

1. Isoproterenol ............................................. 1312. Oral Contraceptives .................................... 131

C. Patient Package Inserts .................................... 132D. The Patient Package Insert (PPI) Program .............. 133

1. Proposal of the Program ............................... 1332. Final Regulations Issued ............................... 1343. Stay of the Final Regulations ......................... 1354. Revocation of the Program ............................. 136

V. RATIONALE FOR RE-ENACTING THE PPI PROGRAM .......... 136A. Failure of the Voluntary Programs ....................... 136B. Increased Patient Participation ............................ 137C. Prescription Drug Advertising ............................ 137

V I. CONCLUSION ..................................................... 138

1Published by EngagedScholarship@CSU, 1991

CLEVELAND STATE LAW REVIEW

I. INTRODUCTION

It has been more than ten years since the Food and Drug Administra-tion proposed regulations which would have required detailed patientinformation for all prescription drugs.' The proposed regulations, in-tended to promote the safe and effective use of prescription drugs,2 wouldhave required a manufacturer to supply nontechnical, 3 nonpromotiona 4

information, referred to as patient package inserts, 5 directly to the pa-tient.6 In response to a directive from President Reagan,7 the final reg-ulations were withdrawn before implementation."

This note will analyze the need for patient information in satisfyingthe tort objectives of informed consent and public safety.9 The note willthen analyze the practical effect of the learned intermediary and informedconsent doctrines upon the manufacturer's and physician's duty to supplypatient information. 0 The note will then analyze the FDA regulationsleading to the proposed patient package insert (PPI) program, the pro-gram itself, the rationale for the program and the reasons for its revo-cation.' Finally, the note will present rationale for re-enacting the FDAregulations.

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II. PATIENT INFORMATION

A. Introduction

Prescription drugs are dangerous compounds which can cause seriousinjury when used improperly and occasionally even when used properly.A patient taking a prescription drug must be supplied with informationconcerning the drug's proper use and symptoms of possible adverse re-actions if the drug's dangerous properties are to be minimized. Providingpatients with adequate information on the proper use of prescriptiondrugs and the risks involved in their use satisfies two tort objectives.

' Prescription Drug Products; Patient Labeling Requirements, 44 Fed. Reg.40,016 (1979) (proposed rule), Prescription Drug Products; Patient Package In-serts Requirements, 44 Fed. Reg. 60,754 (1979) (final rule, codified at 21 C.F.R.§ 203 (1981)).

244 Fed. Reg. 40,016 (1979).3 Id. at 40,016.4Id. at 40,026.5 45 Fed. Reg. 60,754 (1980).644 Fed. Reg. 40,016 (1979).7Exec. Order No. 12,291, 3 C.F.R. § 1267 (1981), reprinted in 5 U.S.C. § 601

at 431-34 (1982).8 Prescription Drug Products; Revocation of Patient Package Insert Require-

ments, 47 Fed. Reg. 39,147 (1982).9 See infra notes 15-61 and accompanying text.10 See infra notes 62-152 and accompanying text.1 See infra notes 153-200 and accompanying text.12 See infra notes 201-217 and accompanying text.

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First, providing adequate patient information satisfies the disclosure re-quirements of the informed consent doctrine.1 3 Patient information isessential if the patient's consent is to be knowledgeable and, therefore,qualify as informed consent.1 4 Second, providing adequate patient infor-mation aids in limiting the inherently dangerous properties of prescrip-tion drugs. This decreases the incidence of injury and, consequentlydecreases tort liability. Patient information is essential if prescriptiondrugs are to be used safely and effectively.

B. Informed Consent

A physician must obtain the patient's informed consent before initi-ating therapy.15 The patient's consent must be knowledgeable if it is tobe true consent.16 Therefore, the patient must be informed of the risksinvolved in the use of a particular medication so that the patient maybalance the risks and benefits while taking into account "[his own] per-sonal values, lifestyle and attitudes towards risk."'1 7 Without adequatepatient information, the patient's consent is not true consent, but merelyacquiescence to the physician's choice of therapy.

1. Balancing the Risks and Benefits

The benefits of prescription drugs range from treating acne to pro-longing life. The risks of prescription drugs range from mild allergicreactions resulting in minor discomfort, to thromboembolic disease, 18 re-sulting in paralysis or death. The severity of the risk, however, does notnecessarily increase with the benefit of the drug. For example, Accutane,' 9

used to treat severe recalcitrant acne, has been associated with majorfetal abnormalities, 20 while insulin, used to treat diabetes, generallycauses only mild allergic reactions.2"

1" See infra notes 135-140 and accompanying text.14 See infra notes 132-134 and accompanying text.," See infra notes 130-131 and accompanying text.16 See infra notes 132-133 and accompanying text."7 Brushwood & Simonsmeier, Drug Information for Patients, 7 J. LEGAL MED.

279, 282 (1986)."I Thromboembolic disease refers to disorders caused by a thrombus (blood clot)

blocking a blood vessel; such disorders include myocardial infarction or stroke.GOODMAN & GILMAN, THE PHARMACOLOGICAL BASIS OF THERAPEUTICS, 1338, 1435(5th ed. 1985).

'9 PHYSICIAN'S DESK REFERENCE, 1711 (43rd ed. 1989). Acne is associated withoveractive sebaceous glands. Accutane is Hoffman-La Roche's brand name forisotretinoin, which inhibits sebaceous gland function. Id. at 1712.

20 Accutane has been associated with major birth defects when taken by womenwhile pregnant. Id.

21 AMERICAN SOCIETY OF HOSPITAL PHARMACISTS, AFHS-DRUG INFORMATION,

1726-27 (1989). The allergic reactions to insulin include localized itching, redness,swelling, stinging or warmth at the site of injection.

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One argument presented to justify withholding information from thepatient concerning the risks and benefits of a prescription drug is thatthe patient will be intimidated by the possibility of unpleasant side effectsand decide to forego therapy.22 In some circumstances, however, the pa-tient is more likely to forego therapy if he is not adequately informed ofthe risks and benefits of the prescribed medication. For example, medi-cations used to treat hypertension often have mild but annoying sideeffects,2 3 while the disease itself is often symptom free. 24 Adequate patientinformation must be provided if the patient is to understand the seriousconsequences of untreated hypertension 25 and, therefore, be able to in-telligently balance the benefits of limiting those consequences againstthe risks involved in taking the medication. 26

2. Elective and Non-Elective Drugs

Under the learned intermediary doctrine (which is discussed in moredetail infra) a prescription drug manufacturer need not warn the patientdirectly of the risks associated with the use of a prescription drug. 27 Theoral contraceptive drugs, however, are an exception to this general rule.28

In justifying the oral contraceptive exception to the learned intermediarydoctrine, the courts noted that oral contraceptive drugs are used "elec-tively" and, therefore, the patient is actively involved in the decision touse the prescription drug.29 Extending this line of reasoning, prescriptiondrugs can be characterized as "elective" or "nonelective." The "elective"drugs, for example, would include: the oral contraceptives, used to prevent

22 See infra note 146.Hypertension is treated with a variety of drugs and drug combinations. The

more common side effects of antihypertensive drugs include sedation, dizziness,dryness of the mouth and headache. GOODMAN & GiLMAN, supra note 18, at 789(listing side effects of methyldopa).

24 SLBER, HEART DISEASE, 1120-21 (2d ed. 1987). Hypertension is the chronicelevation of blood pressure above the range encountered in the general population.Id. at 212. Hypertension, generally diagnosed by a physician monitoring thepatient's blood pressure, is usually symptom free until the late phases of thedisease when serious pathological consequences begin to appear. Id. at 1120-21.

Hypertension adds to the workload of the heart and arteries. If it continuesfor a long time, the heart and arteries may not function properly. This can damagethe blood vessels to the brain, heart and kidneys, resulting in a stroke, heartfailure or kidney failure. U.S. PHARMAcoPEIAL CONvENTION, USPDI-ADvICE FORTHE PATIENT, 903 (1990) [hereinafter USPDII.

2The FDA, in justifying regulations which would have required patient la-beling for all prescription drugs, noted that patients with hypertension may nottake their prescribed medication because they do not experience symptoms fromthe disease. 44 Fed. Reg. 40,016, 40,020 (1979).

27 See infra notes 74-86 and accompanying text.2 See infra notes 113-127 and accomoanying text.

See, e.g., MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, -, 475N.E.2d 65, 69 (1985); Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867,875 (E.D. Mich. 1985); Stephens v. G.D. Searle & Co., 602 F. Supp. 379, 380 (E.D.Mich. 1985).

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pregnancy; Rogaine,30 used to treat baldness; and Accutane, 31 used to treatacne. The "non-elective" drugs, on the other hand, would include: insulin,used to treat diabetes; Lanoxin, 32 used to treat heart failure; and Di-lantin, 3 used to treat convulsions.

The need for patient information, however, is not limited only to "elec-tive" drugs. The FDA has stated that it "does not agree that informationabout serious adverse reactions and safety hazards should only be re-quired for so-called "elective" drug products. The agency is confident thatmost patients can participate in the evaluation of the risks and benefitsfrom drug products. ...

C. Ensuring Safety and Efficacy

Patient information is necessary for all prescription drugs, elective andnon-elective, if they are to be used safely and effectively. Ensuring thesafe and effective use of prescription drugs decreases the incidence ofinjury and, thus, tort liability. The safe and effective use of prescriptiondrugs entails using the drug properly as well as limiting the occurrenceand severity of adverse reactions. Patient information consists of patientinstructions on the proper use of prescription drugs and patient warningsconcerning the risks. Patient instructions can improve patient complianceand decrease the incidence of drug interactions, thereby decreasing theoccurrence of adverse reactions. 5 Patient warnings can decrease the se-verity of adverse reactions by allowing earlier recognition of possibleadverse reactions. Patient warnings can also improve patient complianceby informing patients of frightening but minor side effects.

3o PHYSICIAN's DESK REFERENCE, supra note 19, at 2181. Rogaine is UpjohnCompany's brand name for a 2% topical solution of minoxidil used to promotehair growth. Id. Minoxidil is also marketed by Upjohn Company in a tablet formused for treatment of hypertension. Id. at 2171. Patients using the tablet formof minoxidil to treat hypertension noticed elongation, thickening, and enhancedpigmentation of body hair. The drug was subsequently tested and approved foruse as a hair growth stimulant.

31 See supra note 19.32 PHYSICIAN'S DESK REFERENCE, supra note 19, at 778. In congestive heart

failure, cardiac output diminishes due to decreasing contractile strength of theheart muscle. Lanoxin is Burroughs Wellcome Company's brand name for digoxin,a cardiac glycoside which increased cardiac output by increasing the contractilestrength of the heart muscle.

I Id. at 1541. Dilantin is Parke Davis's brand name for phenytoin which isused to prevent and control seizures or convulsions.

44 Fed. Reg. 60,754, 60,764 (1980) (is codified at 21 C.F.R. Part 203).See, e.g., Malahy, The Effect of Instruction and Labeling on the Number of

Medication Errors Made by Patients at Home, 23 AM. J. Hosp. PHARMACY 282(1966); Hulka, Kupper, & Cassel, Communication, Compliance and ConcordanceBetween Physician and Patients with Prescribed Medications, 66 AM. J. PuB.HEALTH 847 (1976); Morris & Halperin, Effect of Written Drug Information onPatient Knowledge and Compliance, 69 AM. J. PUB. HEALTH 47 (1979).

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1. Patient Instructions

a. Patient Compliance

Informing the patient of the consequences of improperly taking a pre-scription drug improves patient compliance, enhancing safety and effi-cacy. Many prescription medications must be taken on a prescribed dosageschedule to maintain therapeutic blood levels.3 6 Taking the medicationless often or at a lower dose than prescribed may result in subtherapeuticblood levels, causing the drug to be ineffective. 37 Taking the medicationmore often or at a higher dose than prescribed may result in toxic bloodlevels, causing severe adverse reactions. 8 For example, toxic levels ofDilantin, an anticonvulsant, actually causes convulsions3 9 It is foresee-able that a patient with toxic blood levels of Dilantin, knowing the med-ication is for convulsions, may increase the dose of the medication tocounteract convulsions which the medication itself is causing. A patientaware that toxic levels of Dilantin can actually cause convulsions is morelikely to consult his physician before changing the dose of his medica-tion.

40

b. Drug Interactions

Patient instructions include informing the patient of possible drug in-teractions. Some medications act differently if taken concurrently withother medication. 41 Warning the patient of possible drug interactionscan decrease the incidence of adverse reactions, enhancing safety and

3r GOODMAN & GILMAN, supra note 18, at 3-48. Blood levels are measured bydetermining the concentration of drug in the blood plasma. The concentration isgenerally measured in terms of the number of micrograms of drug per millimeterof plasma, or mcg/ml. The term therapeutic blood levels refers to drug concen-tration levels where the drug is effective without being toxic. Id.37 Id.-Id.39 GOODMAN & GILMAN, supra note 18, at 452. A good correlation is usually

observed between the total concentration of Dilantin in the blood and its thera-peutic effect. Control of seizures is generally obtained with concentrations above1Omcg/ml, while toxic effects generally develop with concentrations above 20mcg/ml. Id. at 453. See also supra note 36.

40 Dilantin is one of the ten drugs included in a pilot program in FDA regu-lations which would have required patient package inserts for all prescriptiondrugs. 45 Fed. Reg. 60,754, 60,758 (1980). See also infra notes 186-190 and ac-companying text.

41 See, e.g., P. HANSTEN & J. HORN, DRUG INTERACTIONS (6th ed. 1989); FACTSAND COMPARISONS, DRUG INTERACTION FACTS (1988); WEIBERT & NORCROSS, DRUGINTERACTIONS INDEX (2d ed. 1988).

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efficacy. Coumadin,42 an anticoagulant,43 is more effective if taken with

aspirin.44 If a patient taking both aspirin and coumadin is cut severely,the enhanced anticoagulant effect, caused by the aspirin, may make itdifficult to stop the blood loss. 45 Flagyl, 4

6 an antibiotic, will cause severe

nausea and vomiting if the patient drinks even a minimal amount ofalcohol while taking the medication. 47 Many over the counter cough syr-ups contain alcohol. 48 A patient taking Flagyl needs to be informed of thedrug's interaction with alcohol as well as the need to check the ingredientsof other medications which may contain alcohol.

2. Patient Warnings

a. Recognition of Adverse Reactions

A patient who is fully informed of the risks of adverse reactions andthe symptoms attending them will be better able to recognize an adversereaction before it fully develops, thereby decreasing the severity of thereaction. 49 For example, a patient taking Chloromycetin, 50 an antibiotic,

42 PHYSICIAN's DESK REFERENCE, supra note 19, at 902. Coumadin is Du Pont

Pharmaceutical's brand name for warfarin sodium, an anticoagulant used todecrease the clotting ability of the blood and therefore help to prevent harmfulclots from forming in the blood vessels.

An anticoagulant is a drug which prevents blood clots from being formed inthe blood vessels. USPDI, supra note 25, at 1452. Clotting or coagulation is thebody's protective mechanism for stopping blood loss from a severed blood vessel.

PHYSICIAN'S DESK REFERENCE, supra note 19, at 903. See also USPDI, supranote 25, at 130. A portion of the warfarin in the blood is bound to protein. Protein-bound warfarin is inactive. Aspirin displaces the warfarin on the protein, con-verting it to the active unbound form and increasing its therapeutic affect.

4 Coumadin is one of the ten drugs included in a pilot program in FDA reg-ulations which would have required patient package inserts for all prescriptiondrugs. See infra notes 186-190 and accompanying text.

46 PHYSICIAN'S DESK REFERENCE, supra note 19, at 2014-15. Flagyl is G.D.Searle & Company's brand name for metronidazole, an antibiotic used to treatserious infections.

41 Id. Alcohol should not be consumed while taking metronidazole and for atleast one day afterward. Metronidazole interferes with the metabolism of ethanolresulting in high concentrations of acetaldehyde in the blood. High blood ace-taldehyde concentrations may cause abdominal cramps, nausea, vomiting, head-aches, and flushing.

4 See, e.g., FACTS AND COMPARISONS, DRUG FACTS AND COMPARISONS 836-45(1989).

49 Thompson, The Drug Manufacturer's Duty to Warn, 13 FLA. ST. U.L. REV.

136, 150 (1985).The average patient does not see a physician when the early danger signsappear, because the significance of the danger is not recognized.... In manyclinical circumstances, the patient continues ... taking the drug until se-rious problems develop which provide the incentive to return to a physi-cian.... The time delay may spell the difference between safety andcatastrophe.

Id. (quoting M. Dixon, DRUG PRODUCT LIABILITY § 9.02[2], at 9-14.12).5o PHYSICIAN'S DESK REFERENCE, supra note 19, at 1531. Chloromycetin is the

Parke-Davis's brand name for chloramphenicol, a broad spectrum antibiotic ef-fective against a wide range of bacterial infections. Due to the possibility of seriousand fatal blood dyscrasisas associated with the use of chloramphenicol, its use isgenerally reserved for serious infections only.

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may ignore a sore throat which is an early symptom of aplastic anemia,51

a rare but life threatening adverse reaction. In justifying regulationswhich would have required patient information for all prescription drugs,the FDA stated: "A patient who is informed about the potential adverseeffects of a drug product is better able to monitor his or her reactions tothe product and to take appropriate action if an adverse effect occurs. '52

b. Patience Compliance

Warning the patient of possible mild adverse effects can improve patientcompliance. A patient is less likely to discontinue a medication if he isaware that a minor side effect is not a symptom of a more severe adversereaction. For example, Pyridium, 53 used for urinary tract infections,causes the urine to turn bright orange.5 4 A patient who is not informedthat discoloration of the urine is a normal side effect of the drug maybecome alarmed and discontinue the medication.

D. Advantages of Written Patient Information

In order for prescription drugs to be used safely and effectively, thepatient must receive, understand and remember patient information con-cerning the drug's proper use and possible adverse side effects. 5 The FDAconducted numerous studies, surveys and public hearings before pro-mulgating regulations which would have required manufacturers to sup-ply patient information for all prescription drugs.56 The FDA determined:

51 THE MERK IANuAL 263 (12th ed. 1972). See also USPDI, supra note 25, at343 (listing the symptoms for blood disorders of which the patient should beaware). (USPDI-Advice for the Patient is a book providing information on pre-scription drugs written in lay language. The information provided includes: thegeneric name, common brand names, general information on the use of the med-ication, including: "Before Using This Medicine," "Proper Use of This Medicine,""Precautions While Using This Medicine," and "Side Effects of This Medicine."

52 45 Fed. Reg. 60,754, 60,764 (1980).52 PHYSICIAN's DESK REFERENCE, supra note 19, at 1595. Pyridium is Parke-

Davis's brand name for phenazopyridine, a urinary tract analgesic agent. Urinarytract infections can be very painful. Phenzopyridine helps to relieve the pain byacting as a topical analgesic as it is excreted in the urine. The local action ofphenazopyridine is preferable to systemic analgesics which may cause drowsiness.

Id. Phenazopyridine is chemically related to the azo dyes.5544 Fed. Reg. 40,016, 40,019-20 (1979). The FDA determined that commu-

nicating prescription drug information to the patient can be summarized into fivebasic steps: 1) the patient must be exposed to the information; 2) the patient mustpay attention to the information; 3) the patient must understand the information;4) the patient must accept the information; and 5) the patient must rememberthe information.

44 Fed. Reg. 40,016, 40,018 (1979). For a bibliography of surveys and studiessee id. at 40,035-38. See also infra notes 172-180 and accompanying text.

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1) that most patients do not receive adequate information about prescrip-tion drugs; 2) that information, if provided, is often conveyed in technicallanguage which the patient is unable to understand; and 3) that patientstend to forget information provided orally by the doctor.57

Written information such as patient package inserts are an efficientand effective means of providing patient information. 8 Verbal informa-tion is easily forgotten by the patient, while written information such aspatient package inserts can be retained by the patient and referred to ata later date.5

9

Providing the patient with supplemental information enhances phy-sician-patient communication. 0 A well-informed patient is less likely tobe intimidated by the physician and more willing to ask questions. Thephysician, aware that the patient is well informed, is likely to be moreattentive to the patient's questions. FDA Commissioner Kennedy stated:"[K]nowledge raises the quality of discourse between patient and phy-sician, eliminates unfounded apprehension, increases compliance anddraws the patient into active participation. 6 1

III. PRESCRIPTION DRUG INFORMATION AND THE LEARNEDINTERMEDIARY DOCTRINE

A. The Manufacturer's Duty to Warn and the LearnedIntermediary Doctrine

Ordinarily under products liability law, the manufacturer of a producthas a duty to warn the ultimate user of risks associated with the use of

57 Schwartz, Consumer Warnings for Oral Contraceptives: A New Exception tothe Prescription Drug Rule, 41 FOOD DRUG CosM. L.J. 241, 248 (1986) (citing 44Fed. Reg. 40,016, 40,020 (1979)).

5844 Fed. Reg. 40,016, 40,021 (1979) (stating that a review of the studies onwritten information suggests that it improves communication of important in-formation to patients). See also, Hulka, Kupper, & Cassel, Communication, Com-pliance and Concordance Between Physician and Patients with PrescribedMedications, 66 AM. J. PUB. HEALTH 847 (1976); Morris & Halperin, Effect ofWritten Drug Information on Patient Knowledge and Compliance, 69 AM. J. PuB.HEALTH 47 (1979).

1944 Fed. Reg. 40,016, 40,020 (1979) (stating that studies show that patientsdo not remember information that is presented orally).

6045 Fed. Reg. 60,754, 60,760 (1980). The FDA stated that written drug in-formation will improve communication of important information to patients, willaugment information provided orally and will promote communication betweenhealth care professional and patients.

"I Kennedy, Remarks of the Commissioner of Food and Drugs, 32 FOOD DRUGCosM. L. J. 384, 386-87 (1977).

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the product.6 2 Prescription drugs, however, are an exception to this gen-eral rule.63 Manufacturers of prescription drugs need only warn the pre-scribing physician, who acts as a learned intermediary between themanufacturer and the consumer.64

1. Rationale of the Learned Intermediary Doctrine

Prescription drugs may cause injury even when used correctly; however,the benefits in treating disease generally outweigh the risk of injury.Prescription drugs, therefore, are considered "unavoidably unsafe".6 5 Toavoid liability, the manufacturer of an "unavoidably unsafe product" mustconvey an adequate warning of the risks involved in the use of the productto the ultimate user.66 The manufacturer "of such products ... is not tobe held to strict liability for unfortunate consequences attending theiruse, merely because he has undertaken to supply the public with an

62 Ordinarily under products liability law, the manufacturer of a product isstrictly liable for injuries caused by defects in the product, even if all due care isexercised in its manufacture. A product may be defective due to: 1) a flaw in theproduct (a construction defect); 2) failure to warn (an inadequate warning con-cerning risks associated with use of the product); or 3) a design defect (a productdesign which poses undue risks). PROSSER AND KEETON ON THE LAW OF TORTS

694-702 (5th ed. 1984).See infra notes 74-85 and accompanying text.

-Id.RESTATEMENT (SECOND) OF TORTS § 402A comment K (1965): Unavoidably

unsafe products.There are some products which, in the present state of human knowledge,are quite incapable of being made safe for their intended and ordinary use.These are especially common in the field of drugs. [emphasis added] Anoutstanding example is the vaccine for the Pasteur treatment of rabies,which not uncommonly leads to very serious and damaging consequenceswhen it is injected. Since the disease itself invariably leads to a dreadfuldeath, both the marketing and the use of the vaccine are fully justified,notwithstanding the unavoidable high degree of risk which they involve.Such a product, properly prepared, and accompanied by proper directionsand warnings, is not defective, nor is it unreasonably dangerous. The sameis true of many other drugs, vaccines, and the like, many of which for thisvery reason cannot legally be sold except to physicians, or under the pre-scription of a physician. It is also true in particular of many new or exper-imental drugs as to which, because of lack of time and opportunity forsufficient medical experience, there can be no assurance of safety, or perhapseven of purity of ingredients, but such experience as there is justifies themarketing and use of the drug notwithstanding a medically recognizablerisk. The seller of such products, again with the qualification that they areproperly prepared and marketed, and proper warning is given, where thesituation calls for it, is not to be held to strict liability for unfortunateconsequences attending their use, merely because he has undertaken tosupply the public with an apparently useful and desirable product, attendedwith a known but apparently reasonable risk.

Id." Id.

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apparently useful and desirable product, attended with a known but ap-parently reasonable risk. 67

A prescription drug, "properly prepared and accompanied by properdirections and warnings, is not defective nor is it unreasonably danger-ous. '68 [emphasis in original] The prescription drug manufacturer, how-ever, need not convey the directions and warnings directly to the ultimateuser, the patient.6 9 The courts have determined that the risks associatedwith the use of prescription drugs can only be adequately evaluated bya medical expert.70 Therefore, a special rule known as the learned inter-mediary doctrine has been applied to prescription drugs. Under the doc-trine, a prescription drug manufacturer need only warn the prescribingphysician of the risk involved in the prescription drug's use.71 The phy-sician then acts as a learned intermediary between the manufacturer andthe patient. 72 It is the prescribing physician's duty to warn the patientof the risks associated with the use of the prescription drug. Liability forinjury resulting from a failure to adequately warn is, therefore, shiftedfrom the manufacturer to the physician. 73

2. Development of the Doctrine

In Marcus v. Specific Pharmaceuticals, Inc.,74 a 1948 case, the courtheld that a prescription drug manufacturer's duty to warn is fulfilled bygiving adequate warning to the prescribing physician.7 5 The language ofthe case, however, indicates that the court was primarily concerned withthe concept of privity and the fact that the manufacturer made no rep-resentations to the patient directly.76 Subsequently, in Love v. Wolf,7 7 a1964 case, the 13 Court of Appeals for the Third District of California

67 Id.-Id.69 See infra notes 77-86 and accompanying text.70 See infra notes 86-88 and accompanying text.71 Id.72 Id.73 Id.71 191 Misc. 285, 77 N.Y.S.2d 508 (N.Y. Sup. Ct. 1948). The plaintiff in Marcus

brought action to recover for the death of a 13-month-old child resulting from anoverdose of suppositories administered as prescribed by a physician. Plaintiffalleged that the manufacturer was negligent in failing to manufacture a sup-pository for use by very young infants and for not adequately informing physiciansof the proper dosage for very young infants. The court granted defendant man-ufacturer's motion for dismissal stating: "There is no reason to believe that aphysician would care to disregard his own knowledge of the effects of drugs andhence of the quantity to be administered, and substitute for his own judgmentthat of a drug manufacturer." Id. at __, 77 N.Y.S. at 510.

75 Id. at -, 77 N.Y.S.2d at 509.76 Id.77 226 Cal. App. 2d 378,38 Cal. Rptr. 183 (1984). The plaintiff in Love developed

aplastic anemia, a degenerative disease of the bone marrow, after the plaintiff'sphysician had prescribed Chlormomycetin, an antibiotic, for a mild infection. Themanufacturer had warned physicians of the risk of aplastic anemia and hadadvised physicians that the drug should not be used for minor infections. Thecourt stated that the manufacturer's warnings were sufficient to shift the dutyof warning the patient to the prescribing physician.

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held that "if adequate warning of potential dangers of a drug has beengiven to doctors, there is no duty by the drug manufacturer to insure thatthe warning reaches the doctor's patient for whom the drug is pre-scribed."

7 8

Sterlinq Drugs, Inc. v. Cornish7s appears to be the first case to use theterm "learned intermediary" to describe the special role the physicianplays between the patient and the prescription drug manufacturer. 0 InSterlinq, the Eighth Circuit Court of Appeals stated that in a case "dealingwith a prescription drug ... the purchaser's doctor is a learned inter-mediary between the purchaser and the manufacturer."sl

As learned intermediary between the manufacturer and patient, it isthe physician's "duty to inform himself of the qualities and characteristicsof those products which he prescribes. . . and to exercise an independentjudgment, taking into account his knowledge of the patient as well asthe product. 8 2 The physician balances the risks and benefits of the pre-scription medication for the patient 3 and then decides what facts con-cerning the risks associated with prescription drugs will be told to thepatient.8 Under the learned intermediary doctrine, "[t]he patient is ex-pected to and, it can be presumed, does place primary reliance upon thatjudgment."

8 5

The learned intermediary doctrine has received "virtually unanimousacceptance and remains the general rule. '88 The court in Reyes v. Wyeth

78 Id. at -, 38 Cal. Rptr. at 193.79 370 F.2d 82 (8th Cir. 1966). The plaintiff in Sterling developed chloroquine

retinopathy, a degenerative disease of the eye, resulting from the use of Aralen,a drug used to treat arthritis. The court held that the manufacturer had a dutyto warn doctors of the side effect.

MId. at 85.I' Id.

82 Terhune v. A.H. Robins Co., 90 Wash. 2d 9, __, 577 P.2d 975, 978 (1978).See, e.g., Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974)

("His [the physician's] is the task of weighing the benefits of any medicationagainst its potential dangers").

Terhune, 90 Wash. 2d at -, 577 P.2d at 978.& Id.

In re Certified Questions, 419 Mich. 686, __, 358 N.W.2d 873, 881 (1984)(Boyle, J., dissenting) (stating: "Other jurisdictions have been virtually unani-mous in adopting the learned intermediary doctrine for all prescription drugs

.") (footnotes omitted). For a list of cases adopting the learned intermediarydoctrine, see Id. at 881 n.4.

In In re Certified Questions, the United States District Court for the EasternDistrict of Michigan certified questions arising from two cases concerning themanufacturer's duty to warn patients directly of the risks associated with the useof a prescription drug: Odgers v. Ortho Pharmaceutical, No. 78-70543 (E.D. Mich.Feb. 18, 1983) (plaintiff alleged that her paralysis was caused by a blood clotresulting from her use of Ortho Novum, an oral contraceptive); and Granger v.Sandoz Pharmaceutical, No. 79-40075 (E.D. Mich. Feb. 18, 1983) (plaintiff allegedinjury resulting from the use of Mellaril, an antipsychotic drug).

The majority opinion concluded that the questions could not be decided byapplying existing case law and were best left for the legislature. In re Certifiedat 691-92, 697, 358 N.W.2d at 874, 877. The dissenting opinion, adopted by theOdgers court in its final opinion, argued that a manufacturer of oral contraceptivesdoes have a duty to warn; however, this duty is not imposed for other drugs. Id.at 698-718, 358 N.W.2d at 878-87.

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Laboratories8 7 articulated the rationale for the judiciary's acceptance ofthe learned intermediary doctrine.

[Wihere prescription drugs are concerned, the manufacturer'sduty to warn is limited to an obligation to advise the prescrib-ing physician of any potential dangers that may result fromthe drug's use. This special standard for prescription drugs isan understandable exception to the Restatement's general rulethat one who markets goods must warn foreseeable ultimateusers of dangers inherent in his products. Prescription drugsare likely to be complex medicines, esoteric in formula andvaried in effect. As a medical expert, the prescribing physiciancan take into account the propensities of the drug, as well asthe susceptibilities of his patient. His is the task of weighingthe benefits of any medication against its potential dangers.8

3. Decline of the Doctrine

In spite of the judiciary's acceptance of the learned intermediary doc-trine, the continued viability of the doctrine is in question. 89 As currentlyapplied, the learned intermediary doctrine substantially overstates theability and willingness of the medical community to act as a learnedintermediary. 90 Patients do not receive adequate information concerningthe proper use of prescription medication. Studies indicate that fifty tosixty percent of the patients using prescription drugs do not take themproperly.9' Studies also indicated that the frequency of medication erroris directly related to the inadequacy of the information received by pa-tients.92 By placing the duty to warn on the physician who has sole dis-cretion in deciding what will be told to the patient, the current systemignores the benefits of having an informed patient.93 "Courts, commen-tators and legislators have become increasingly cognizant of the obso-

81 98 F.2d 1264 (5th Cir. 1974). See infra notes 98-102 and accompanying textfor a discussion of the case.

Id. at 1276.81 See infra notes 113-27, 172-93, 212-17 and accompanying text.

Thompson, supra note 49, at 143.9, 44 Fed. Reg. 40,016, 40,021 (1979). See also Hect, Medicine and the Elderly,

17 FDA CONSUMER 20, 22 (1983) (indicating noncompliance at 50-60%).92 See, e.g., Malahy, The Effect of Instruction and Labeling on the Number of

Medication Errors Made by Patients at Home, 23 AM. J. HosP. PHARMACY 282(1966); Hulka, Kupper, & Cassel, Communication, Compliance and ConcordanceBetween Physician and Patients with Prescribed Medications, 66 AM. J. PUB.HEALTH 847 (1976); Morris & Halperin, Effect of Written Drug Information onPatient Knowledge and Compliance, 69 AM. J. PuB. HEALTH 47 (1979).

11 Thompson, supra note 49, at 143.

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lescence of the learned intermediary doctrine '9 4 and have formulatedcertain common law and regulatory exceptions to the general rule.

4. The Mass Immunization Exception

The vaccine cases were the first common law exception to the learnedintermediary doctrine. In Davis v. Wyeth Laboratories,95 the plaintiff con-tracted polio after receiving the Sabin live-virus polio vaccine from apharmacist at a immunization clinic.96 The Ninth Circuit Court of Appealsheld that the manufacturer has a duty to warn patients directly whenthe vaccine is dispensed "without an individualized balancing by a phy-sician of the risks involved. 97

In Reyes v. Wyeth Laboratories," the daughter of the plaintiff contractedpolio after receiving the Sabin polio vaccine from a registered nurse ata county health department.9 9 The manufacturer had included in the drugpackage a pamphlet warning of the risks associated with the vaccine, 100

but the nurse did not inform the plaintiff of the risks. 10 1 Relying on theholding in Davis, the Fifth Circuit Court of Appeals held that the man-ufacturer has a duty to warn the patient directly when the vaccine is"dispensed without the sort of individualized medical balancing of therisks to the vaccinee that is contemplated by the prescription drug ex-ception."

0 2

In Givens v. Lederle,'0 3 the Fifth Circuit Court of Appeals interpretedthe mass immunization exception to the learned intermediary doctrinebroadly. In Givens, the plaintiff claimed that she had contracted poliofrom her child who had been recently vaccinated by a physician.' °4 Inspite of the intervention of the physician between the patient and themanufacturer, the court held that the mass immunization exception tothe learned intermediary doctrine applied and, therefore, the manufac-turer "is responsible for taking definite steps to get the warning directlyto the consumer."'1 5 The court noted the physician's testimony that ad-ministration of the vaccine in a physician's office "really doesn't differ"from that in an immunization clinic.10 6

- Cody, Products Liability-Food, Drug and Cosmetic Law-Birth Control-A DrugManufacturer Who Voluntarily Distributes Patient Pamphlets Has a Duty to WarnPatients of Dangers Associated with Use of the Drug, 49 U. CrN. L. REv. 517, 528(1980).

95 399 F.2d 121 (9th Cir. 1968).Id. at 122-23.Id. at 131.

9' 498 F.2d 1264 (5th Cir.), cert. denied, 419 U.S. 1096 (1974).Id. at 1269-70.

10 Id. at 1270.101 Id.l 2 Id. at 1277.103 556 F.2d 1341 (5th Cir. 1977).'10 Id. at 1343.105 Id. at 1345.106Id.

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A recent case, however, refused to extend the mass immunization ex-ception to a "local program instituted only to immunize certain highschool students who needed the vaccine . ,,.o1 In Walker v. Merck,108 a1986 case, the plaintiff alleged that her child's blindness had been causedby a dose of MMR-I1o 9 vaccine administered to the plaintiff while shewas pregnant with the child." 0 The plaintiff had been given the vaccineby a licensed practical nurse in a clinic-type setting at a local high schoolas part of a county-sponsored immunization program."' The Walker courtstated that "[t]his court will not extend the Davis-Reyes-Givens line ofdecisions beyond their facts, as the exception to the learned intermediaryrule established for polio cases is quite narrow and highly fact specific. 1 2

5. The Oral Contraceptive Exception

The oral contraceptive drugs were the second exception to the learnedintermediary doctrine. In 1970, prompted by studies indicating thatwomen using oral contraceptives were more likely to develop throm-boembolic disease,"13 the FDA enacted regulations requiring manufac-turers of oral contraceptives to supply warnings directly to the patient.14

Some courts have expanded on this regulatory exception to the learnedintermediary doctrine." 5 These courts have held that manufacturers oforal contraceptives have a common law duty to warn patients directlyand that the adequacy of that warning is determined by applicable statelaw and not by FDA regulations."16

107 Walker v. Merck, 648 F. Supp. 931, 934-35 (M.D.Ga. 1986).108648 F. Supp. 931.109 MMR-II is Merck Sharp and Dome's brand name for its Measles, Mumps

and Rubella virus vaccine. PHYsiciAN'S DESK REFERENCE, supra note 19, at 1351.110 Walker, 648 F. Supp. at 932."I1 Id.

'12 Id. at 934.113 See Vessey & Doll, Investigation of the Relation Between Use of Oral Con-

traceptives and Thromboembolic Disease, BRIT. MED. J. 199 (1968).114 In 1970, the FDA issued 21 C.F.R. § 130.45 (1970) which required that abrief warning directed to the patient be included in the oral contraceptive package.The regulations required a brief statement that the use of oral contraceptivescould cause serious side effects, including abnormal blood clotting. In 1974, theFDA withdrew 21 C.F.R. § 130.45 and replaced it unchanged with 21 C.F.R. §310.501. In 1978, the FDA amended 21 C.F.R. § 310.501. The amendment requiredthat a detailed patient package insert accompany each packet of oral contracep-tives dispensed and also required that a brief summary of the detailed informationalso be included. The brief summary was required to include: 1) a list of con-traindications; 2) a list of serious side effects; 3) a highlighted statement thatsmoking increases the risk of serious side effects; and 4) a statement encouragingthe patient to read the detailed patient package insert. For detailed informationconcerning the requirements, see 43 Fed. Reg. 4214 (1978).

"I See infra notes 120-27 and accompanying text.116 Id.

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I In Lukaszewicz v. Ortho Pharmaceutical Corp. ,l7 the court implied thatmanufacturers had a common law duty to warn users of oral contracep-tives directly of the risks associated with the use of the "pill".118 In anamended opinion, however, the court stated that it was relying entirelyupon the FDA regulations and not upon a common law duty to warn. 119

Then in MacDonald v. Ortho Pharmaceutical Corporation,120 the Massa-chusetts Supreme Court held that "the manufacturer of oral contracep-tives is not justified in relying on warning to the medical profession tosatisfy its common law duty to warn, and that the manufacturer's obli-gation encompasses a duty to warn the ultimate user."'' The court also

held that supplying the patient with a warning which satisfied FDA

regulations 12 2 did not preclude an action at common law concerning theadequacy of the warning. 23

In justifying the oral contraceptive exception to the learned interme-diary doctrine, the court noted: 1) that oral contraceptives are electivedrugs taken by healthy women who are actively involved in the decisionto use them; 2) that there is a high incidence of side effects associatedwith the use of oral contraceptives; and 3) that due to the complexity ofthe information involved, oral communication by the physician does notadequately inform the patient.2 4

117510 F. Supp. 961 (E.D. Wis.), modified, 532 F. Supp. 211 (E.D. Wis. 1981).The plaintiff in Lukaszewicz alleged that the defendant manufactured and soldOrtho-Novum, an oral contraceptive, in a defective condition unreasonably dan-gerous to the plaintiff and that as a result of her use of the product she suffereda cerebral vascular accident. Id. at 962.

118 510 F. Supp. at 965.119 532 F. Supp. at 211.120 394 Mass. 131, 475 N.E.2d 65 (1985), cert. denied, 474 U.S. 920 (1985). The

plaintiff in MacDonald alleged that a stroke and resulting injuries were causedby the manufacturer's failure to warn users of the risk of stroke. Id. at 132-35,475 N.E.2d at 66-68.

121 Id. at 138, 475 N.E.2d at 70.122 See supra note 114.12 394 Mass. at 139, 475 N.E.2d at 70. In justifying its holding the court noted

a statement made by the FDA Commissioner in the preamble to the regulationsamending and expanding the labeling requirements for oral contraceptives. Id.The Commissioner stated:

The Commissioner does not agree that the imposition of a requirement forpatient labeling will necessarily affect adversely the standard of civil tortliability which is imposed on drug manufacturers or dispensers. Whetheror not a corporation or individual is to be held liable in a given situationwill depend upon the facts surrounding the manufacture, sale, and use ofthe drug product, and on the nature of the injury. It will also depend on theapplicable state law, which the Commissioner notes can be adjusted by statecourts and legislatures in light of the facts presented by patient labeling.

43 Fed. Reg. 4214, 4214 (1978). The court interpreted the Commissioner's state-ment as supporting the creation of standards under state law which may exceedthe FDA requirements. MacDonald, 394 Mass. at 139, 475 N.E.2d at 70. For adiscussion of the difficulties accompanying individual state standards, see infranotes 128-29 and accompanying text.

12 394 Mass. at 138, 475 N.E.2d at 69-70.

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In two federal cases 125 decided in the same year as MacDonald, theDistrict Court for the Eastern District of Michigan also held that man-ufacturers of oral contraceptives have a common law duty to warn patientsdirectly of the risks associated with the use of oral contraceptives' 2 andthat supplying a warning which complies with FDA regulations does notnecessarily preclude an action at common law concerning the adequacyof the warning. 127

Expansion of the oral contraceptive exception to the learned interme-diary doctrine on a jurisdiction by jurisdiction basis may result in incon-sistent labelling requirements for oral contraceptive manufacturers. Withthe benefit of hindsight, a jury may determine that a manufacturer'swarning was inadequate.' 2 The manufacturer faced with a vague andnebulous standard which might differ from jury to jury would be forcedto provide warnings concerning every possible risk regardless of its se-verity or probability. 29 Faced with a lengthy document detailing everypossible consequence, patients are less likely to read the information,thus defeating the purpose of patient information. A comprehensive reg-ulatory program, such as that proposed by the FDA (discussed in moredetail infra), could avoid conflicting warning requirements by mandatingthat a warning complying with regulations is adequate as a matter oflaw.

B. The Physician's Duty to Warn and the InformedConsent Doctrine

1. Rationale of the Doctrine

"[T]herapy not authorized by the patient may amount to a tort, a com-mon law battery, by the physician.' 130 To avoid liability, therefore, the

125 Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867 (E.D. Mich. 1985)(plaintiff alleged that her use of Ortho-Novum, an oral contraceptive manufac-tured by defendant, caused a blood clot resulting in her paralysis, and that thedefendant had failed to adequately warn of her of the risk); Stephens v. G.D.Searle & Co., 602 F. Supp. 379 (E.D. Mich. 1985) (plaintiff alleged that her useof Ovulen, an oral contraceptive, caused her stroke and that defendant was neg-ligent in not adequately warning her of the risk).

126 Odgers, 609 F. Supp. at 878; Stephens, 602 F. Supp. at 380-81.127 Odgers, 609 F. Supp. at 877-78 ("I am of the opinion that the FDA's regu-

lation of oral contraceptives was not intended in any way to preclude impositionof tort liability for failure to warn."); Stephens, 602 F. Supp. at 381 ("It is clearto this Court that the adequacy of a warning in a products liability case is aquestion for the jury.").

128 See supra notes 120-127 and accompanying text. See also Brushwood &Simonsmeier, supra note 17, at 297-98; Fern, The Decline and Fall of the LearnedIntermediary Doctrine, 28 FOR THE DEFENSE 10, 17 (1986); Knicke, Oral Contra-ceptives: Heading Into an Era of Unpredictability, Unlimited Liability, and Un-availability, 19 IND. L. REv. 615, 634-41 (1986).

129 Brushwood & Simonsmeier, supra note 17, at 298.130 Canterbury v. Spence, 464 F.2d 772, 783 (D.C. Cir. 1972) cert. denied, 409

U.S. 1064 (1972).

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physician must obtain the patient's consent before initiating therapy.'31

True consent is the informed exercise of choice and requires that thepatient have the opportunity to knowledgeably evaluate the therapeuticoptions available and the risks involved in those options.132 In order toensure that the patient's consent is knowledgeable and to protect thecommon law rights of self determination and bodily integrity, the courtsdeveloped the informed consent doctrine.133 The informed consent doctrineis premised on the fundamental concept that "[elvery human being, ofadult years and sound mind" has a right to determine "what shall bedone with his own body."'13 4

2. The Scope of the Duty to Warn

The informed consent doctrine imposes upon the physician a duty towarn the patient of the risks associated with a proposed therapy. 35 Thereare currently two standards for determining the scope of the duty towarn.13 6 Under the traditional customary-practice standard, the scope ofthe duty to warn is determined by the standard of practice in the medicalcommunity.' 37 The physician is not under a duty to warn unless the med-ical community has determined that the disclosure is necessary. 38 One

1Id. at 782.132 Id. at 780.- Tietz, Informed Consent in the Prescription Drug Context: The Special Case,

61 WASH. L. REV. 367, 370 (1986).134 Canterbury, 464 F.2d at 780 (quoting Schloendorff v. Society of N.Y. Hosp.,

211 N.Y. 125, 105 N.E. 92, 93 (1914)).15 For a detailed analysis of the informed consent doctrine in reference to

prescription drugs, see Tietz, supra note 133; Schultz, From Informed Consent toPatient Choice: A New Protected Interest, 95 YALE L.J. 219 (1985).136 Tietz, supra note 133, at 368. There are three elements which must be proven

to establish a breach of the duty to warn: 1) whether the physician had a dutyto warn; 2) the scope of that duty; and 3) if the duty was breached, whether thebreach proximately caused the patient's injury (that is, whether the patient wouldhave refused consent had he been adequately informed). Id. at 371-72.

137 See, e.g., Watkins v. United States, 482 F. Supp. 1006 (M.D. Tenn. 1980);Finley v. United States, 314 F. Supp. 905 (N.D. Ohio 1970); Carmichael v. Reitz,17 Cal. App. 3d 958, 95 Cal. Rptr. 381 (1971); Calabrese v. Trenton State College,162 N.J. Super. 145, 392 A.2d 600 (1978), affd, 82 N.J. 321, 413 A.2d 315 (1980);Koury v. Follo, 272 N.C. 366, 158 S.E.2d 548 (1968); Boyer v. Smith, 345 Pa.Super. 66,497 A.2d 646 (1985); Malloy v. Shanahan, 280 Pa. Super. 440,421 A.2d803 (1980); Kaiser v. Suburban Transp. Sys., 65 Wash. 2d 461, 398 P.2d 14 (1965);Trogun v. Fruchtman, 58 Wis. 2d 596, 207 N.W.2d 297 (1973). Tietz, supra note133, at 368 n.8.

138 See Kaiser v. Suburban Transp. Sys., 65 Wash. 2d 461, 464, 398 P.2d 14, 16(1965) (to determine what warnings are to be given with a prescription drug, acourt should look to what the medical community usually discloses); Natansonv. Kline, 186 Kan. 393, 350 P.2d 1093, 1106 (1960) ("The duty of the physicianto disclose .. . is limited to those disclosures which a reasonable medical prac-titioner would make under the same or similar circumstances."). Tietz, supra note133, at 372 n.28.

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commentator has noted that courts have found the current standard ofpractice for physicians in some communities is to keep the patient com-pletely ignorant. 139

The courts, recognizing the inherent conflict in allowing physicians todetermine for themselves the scope of the duty to warn, developed thereasonable-patient standard. Under the reasonable-patient standard, thescope of the physician's duty to warn is determined by what informationa reasonable patient would find material in weighing the risks and ben-efits of the proposed therapy.140

Canterbury v. Spence'14 is the leading case establishing a reasonable-patient standard. In Canterbury, the District of Columbia Court of Ap-peals found that the duty to warn is independent of the patient's requestfor disclosure and that the standard for review is not the standard set bycustom of physicians practicing in the community. 42 The Canterburycourt stated: "Respect for the patient's right of self-determination onparticular therapy demands a standard set by law for physicians ratherthan one which physicians may or may not impose upon themselves.' '14 3

3. The Doctrine and Prescription Drugs

Canterbury dealt with the patient's consent to a surgical procedure. 44

In the case of prescription drugs, however, the courts almost universallycontinue to apply the more limited customary-practice standard.145 Ascurrently applied, the informed consent doctrine overstates the willing-ness of the medical community to adequately inform patients of the risksassociated with the use of prescription drugs. When prescribing prescrip-

139 Thompson, supra note 49, at 148 (citing M. DIXON, DRUG PRODUCT LIABILITY§ 7.23, 7-110 (1974)).

40 Tietz, supra note 133, at 368.

141 464 F.2d 772, (D.C. Cir.) cert. denied, 409 U.S. 1064 (1972). The plaintiff inCanterbury, a youth troubled by back pain, submitted to a laminectomy, an op-eration to correct the condition. The plaintiff was not informed of the risk ofparalysis incidental to the procedure. The day after the operation the youth fellfrom his hospital bed after being left unattended. A few hours after the fall, thelower half of plaintiffs body was paralyzed. Despite another operation and ex-tensive medical care the plaintiff remained partially paralyzed. Id. at 776. Thecourt held that every human being, and thus every medical patient, of adult yearsand sound mind has a right to determine what shall be done with his own bodyand that true consent is the informed exercise of choice, entailing opportunity toevaluate knowledgeably the options available and the risks attendant upon each.Id. at 780.

142 Id. at 783-84. The court held that the physician is under an obligation tocommunicate specific information to the patient when required by the exigenciesof reasonable care. Id. at 781. The court stated that the test for determiningwhether a particular risk must be disclosed is its materiality to the patient'sdecision. Id. at 786-87.

143 Id. at 784.- Id. at 776.45 Tietz, supra note 133, at 369. See also supra note 138.

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tion drugs, physicians tend not to inform patients of the less common butmore severe adverse reactions as they believe the patient may be fright-ened into not taking the medication. 1 6 The current standard of practicefor physicians in some communities is to keep the patient completelyignorant of the risks involved in the use of prescription drugs. 147 A Galluppoll taken before FDA regulations required patient package inserts fororal contraceptives indicated that two-thirds of the women surveyed hadnot been told of the risks associated with the use of oral contraceptives. 148

"Optimally for the patient, [disclosure] of a risk would be mandatorywhenever the patient would deem it significant to his decision.... -149Physicians should be required to inform patients of therapeutic alter-natives, the risks involved and any other information material to thepatient's informed choice. 10

As currently applied, the informed consent doctrine also overstates theability of physicians to adequately inform patients of the risks involvedin the use of prescription drugs. Advances in science have increased thequantity and complexity of the information available concerning pre-scription drugs. The sheer volume of drug literature concerning prescrip-tion drugs is overwhelming and "militates against the physician beinginformed of all the hazards of a particular drug .... ."151 Patient infor-mation in the form of patient package inserts (discussed in more detailinfra), would not result in similar inundation as the patient is not con-cerned with knowing the risk of a broad spectrum of drugs but only risksof the drug prescribed. 52

- See, e.g., Plummer v. Lederle Laboratories., 819 F.2d 349, 352, cert. denied,484 U.S. 898 (1987); Pharmaceutical Mfrs. v. FDA, 484 F. Supp. 1179, 1190 (1980);Terhune v. A.H. Robins Co., 90 Wash.2d 9, 12, 577 P.2d 975, 979 (1978); Odgersv. Ortho Pharmaceutical Corp., 609 F. Supp. 867, 878, (E.D. Mich. 1985). See alsoRheingold, Products Liability-The Ethical Drug Manufacturer's Liability, 18 RUT-GERS L. REV. 947,987 (1964); J. KATZ, THE SILENT WORLD OF DOCTOR AND PATIENT83 (1984). See also 42 Fed. Reg. 37,636 (1977).

147 See supra note 139.- Rincke, Oral Contraceptives: Heading Into an Era of Unpredictability, Un-

limited Liability, and Unavailability?, 19 IND. L. REv 615, 625 (1986).149 Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert. denied, 409 U.S. 1064

(1972), 474 F.2d at 787. However, after stating that optimally the patient's sub-jective concerns should be considered, the court then stated such a requirementwould place an undue demand upon the medical profession and, therefore, thescope of the standard is not subjective as to either the physician or the patientbut remains objective as to the patient's informational needs and with suitableleeway for the physician's situation. Id.

110 Tietz, supra note 133, at 374.151 Thompson, supra note 49, at 145.152 Id.

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IV. FDA REGULATION OF PATIENT INFORMATION

A. Introduction

The FDA has promulgated certain regulatory exceptions to the learnedintermediary doctrine. Beginning in 1968, the FDA determined that cer-tain drugs were not safe unless labelled with nontechnical, 15 3

nonpromotional 5 4 information provided directly to the patient.1 5 TheFDA regulations challenged the assumption which the courts had beenmaking in support of the learned intermediary doctrine that prescriptiondrugs were safe and effective if warnings were supplied only to the pre-scribing physician.

5 6

B. Patient Warnings

1. Isoproterenol

In 1968, the FDA issued regulations requiring manufacturers to warnpatients directly of the hazards associated with the use of isoproterenol.157

Excessive use of isoproterenol, an inhalation drug used by asthmatics,had been shown to cause severe bronchoconstriction making it more dif-ficult for the asthmatic to breathe. 158 Noting that isoproterenol is a self-administered drug whose frequency of use is necessarily determined bythe patient, the FDA promulgated regulations requiring that the inhalerdispensed to the patient be labeled with a specific warning advising thepatient of the danger associated with excessive use.5 9

2. Oral Contraceptives

In 1970, prompted by studies indicating that women using oral con-traceptives were more likely to develop thromboembolic disease than

15144 Fed. Reg. 40,016 (1979).154 Id. at 40,026.151 Id. at 40,016.156 Schwartz, Consumer Warnings for Oral Contraceptives: A New Exception to

the Prescription Drug Rule, 41 FOOD DRUG CosM. L.J. 241, 246 (1986).'1, 33 Fed. Reg. 8812 (1968) (codified at 21 C.F.R. § 201.305).

Id.' Id. The regulations required that the warning be attached to the medication

container or shipped separately with instructions to the pharmacist to label thecontainer before dispensing. The required notice stated: "Warning: Do not exceedthe dose prescribed by your physician. If difficulty in breathing persists, contactyour physician immediately." Id.

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nonusers, 16° the FDA issued regulations requiring that a brief patientwarning be inserted in each package of oral contraceptives. 16 ' The reg-ulations further required that the warning advise the patient that a moredetailed pamphlet was available from the patient's physician. 162 The FDAnoted: 1) that oral contraceptives contain potent steroid hormones; 2) thatthey are used for long periods of time by a large number of women who,for the most part, take them as a matter of choice; and 3) that becauseof their indications, they are sometimes used without adequate medicalsupervision. 163 The FDA determined that "[tihey represent, therefore, theprototype of drugs for which well-founded patient information is desir-able."64

In 1974, under the advice of the National Food and Drug AdvisoryCommittee, the FDA began a patient prescription drug labeling projectto investigate whether FDA patient labeling should be expanded to otherprescription drugs. 6 5 The FDA discussed the program with interestedparties, interviewed parties likely to be affected by the legislation, re-viewed the literature concerning patient needs, and conducted researchto evaluate the effectiveness of labeling in communicating informationto patients.

16 6

C. Patient Package Inserts

In 1977, the FDA amended the regulations requiring patient warningsto include the estrogen drugs16 7 and in 1978, revised the patient warningto include more detailed information. 168 The amended regulations also

'o See Vessey & Doll, Investigation of Relation Between Use of Oral Contra-ceptives and Thromboembolic Disease, BRIT. MED. J. 199 (1968).

161 35 Fed. Reg. 5962 (1970) (proposed rule), Statement of Policy ConcerningOral Contraceptive Labeling Directed to Users, 35 Fed. Reg. 9001 (1970) (finalrule, codified at 21 C.F.R. § 130.45). The required warning stated:

Do NOT TAKE THIS DRUG WITHOUT YOUR DOCTOR'S CONTINUED SUPERVISION.

The oral contraceptives are powerful and effective drugs which can causeside effects in some users and should not be used at all by some women.The most serious known side effect is abnormal blood clotting which canbe fatal.

35 Fed. Reg. at 9002-03.162 Id. at 9003.16 35 Fed. Reg. 5962 (1970).164 I .

165 44 Fed. Reg. 40,016, 40,018 (1979)." Id. at 40,018-19. See also id. at 40,035-38 (bibliography of references).

167 42 Fed. Reg. 37,636 (1977) (codified at 21 C.F.R. § 310.515). The Commis-sioner concluded that the safe and effective use of drug products containing es-trogens requires that patients be fully informed of the benefits and risks involvedin the use of these drugs. Id. at 37,641.

15 43 Fed. Reg. 4,214 (1978) (codified at 21 C.F.R. § 310.501). The FDA statedthat the action was taken to provide consumers with expanded labeling infor-mation reflecting recent reports about the risk of blood clots, other problems ofthe circulatory system, cancer and effects upon unborn children associated withthe use of oral contraceptives. Id.

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required that an individual patient package insert be included with eachprescription dispensed.

169

Unlike isoproterenol and oral contraceptives, the estrogen drugs arenot packaged in unit-of-use containers, and the manufacturer must relyon the pharmacist to dispense the patient warning or patient packageinsert. In Pharmaceutical Mfrs. Ass'n v. FDA, 170 drug manufacturers andpharmaceutical groups challenged the FDA's authority to require patientpackage inserts for estrogen drugs. The Third Circuit Court of Appealsupheld the FDA's regulations based on the FDA's authority to prohibitmisleading labeling of prescription drugs.171 The court determined thatwithout the patient package insert the estrogen labeling was mislead-ing.

172

D. The PPI Program

1. Proposal of the PPI Program

In 1979, the FDA proposed a program requiring mandatory patientpackage inserts, written in nontechnical, nonpromotional language foralmost all prescription drugs. 173 The FDA noted that previous patientlabeling regulations had centered on drugs which presented significantrisks but also afforded the patient the ability to participate with thephysician in choosing whether to use the medication.1 7 4 The FDA statedthat it was taking this action to promote the safe and effective use ofprescription drugs by patients and to ensure that patients have the op-portunity to be informed of the benefits and risks involved in the use ofprescription drugs. 175

The proposal was based on studies showing: 1) that most patients donot receive adequate information from their physician concerning pre-scription drugs;176 2) that oral information from the physician is generallyin technical language, not easily understood;177 3) that oral information

1I1 Id. at 4220-21.170 484 F. Supp. 1179 (D. Del. 1980), affd, 634 F.2d 106 (3d Cir. 1980).171 634 F.2d at 108.172 Id.173 See supra notes 1-6 and accompanying text.17, 44 Fed. Reg. 40,016, 40,018 (1979).171 Id. at 40.016.17 44 Fed. Reg. 40,016, 40,020 (1979). In a national telephone survey of pa-

tients, forty-eight percent of the respondents said that their physician did nottalk to them about their prescription medication. Id. In a study at a clinic thatallowed direct observation of physicians instructing patients, the length of ther-apy was discussed in only ten percent of the cases, the dosage frequency in onlyseventeen percent of the cases, and in seventeen percent of the cases the drugwas never discussed at all. Id.

177 44 Fed. Reg. 40,016, 40,020 (1979). One study revealed, for example, thata mother did not understand that her child was to be hospitalized when she wastold that the child would have to be "admitted for a work up." Id. Although patientsmay not understand what physicians tell them, they may be unwilling to ask forclarification as they do not want to appear stupid or do not want to bother thephysician with "silly" questions. Id.

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is easily forgotten; 178 and 4) that written patient information is moreeffective. 179 The FDA stated that it believes that patient labeling that iswell designed and well written will augment oral communication andwill help overcome the problems which hamper the communication topatients of important information about prescription drugs. 180

2. Final Regulations Issued

In 1980 under the Carter Administration, the FDA issued final regu-lations requiring patient package inserts for prescription drugs (the PPIProgram).' 81 The FDA stated that the regulations resulted from the agen-cy's more than ten years of experience with patient labeling for specificdrugs and that patient package inserts represented a significant initiativefor improving health care. 8 2 The FDA noted that traditionally the extentof patient knowledge on prescription drugs was not available independ-ently to patients, but that recently such information is generally availableat bookstores.8 3 Patients, however, are not necessarily aware of the in-formation's availability nor of its veracity.'8 The FDA stated that itbelieves that providing complete and understandable information to pa-tients can help maximize benefits from prescription drugs, while reducingtheir potential harm.185

The final regulations established a pilot program intended to allow theagency time to evaluate the costs and benefits of patient package insertsbefore moving to a full scale program. 88 The pilot program, to be imple-mented over a three year period, would have required patient packageinserts for ten prescription drugs or drug classes. 187 The regulations re-

178 44 Fed. Reg. 40,016, 40,020 (1979). The FDA noted that although a physicianmay provide oral information to the patient, the patient may not be able to processall of the information. Id. Studies conducted in a clinic show that patients re-member only about half of the statements made to them about their treatment,even when interviewed within minutes after leaving the physician's office. Id.The FDA also noted that the order in which medical information is presentedaffects how easily patients remember it. In general, patients tend to rememberwhat they are told first. In addition, a patient's natural anxiety during an ex-amination may interfere with the patient's ability to focus attention on the in-formation provided. Id.

179 44 Fed. Reg. 40,016, 40,020 (1979).180 Id.11 Prescription Drug Products; Patient Package Inserts Requirements, 45 Fed.

Reg. 60,754 (1980) (codified at 21 C.F.R. § 203).182 Id.183Id.184 Id.185Id.

16 45 Fed. Reg. 60,754, 60,756-57 (1980).187 Id. The drugs or drug classes included: ampicillin, the benzodiazepines,

cimetidine, clofibrate, digoxin, methoxsalen, propoxyphene, phenytoin, thiazides,and warfarin. These drugs and drug classes were selected because the agencybelieved that patient package inserts for these products would significantly en-hance their safe and effective use. Id. at 60,758.

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quired the manufacturer to prepare and supply patient package inserts,which were to be dispensed by a pharmacist or other drug dispenser withthe prescription drug.'" The content of the patient package insert wasto include: product identification, route of administration, indications,contraindications, serious side effects, precautions and general infor-mation.18 9 "Guideline PPI's," examples of patient package inserts thatcomplied with the regulations, were described by the regulations for theten drugs or drug classes included in the pilot program.19

The regulations stated that the patient package inserts were to sup-plement the information traditionally provided by the physician and didnot relieve the physician of his duty to provide information to the pa-tient.19' The regulations also provided that the physician could direct thatthe patient package insert not be provided if he believed it would be inthe patient's best interest, although the dispensing pharmacist wouldstill be required to provide the insert upon the patient's request. 9 2 FDACommissioner Kennedy urged physicians to consider "patient labelingnot as an intrusion, but as an educational resource.. . [which] eliminatesunfounded apprehension, [and] increases compliance. 193

3. Stay of the Final Regulations

In 1981 under the new Reagan Administration, the new FDA Com-missioner Arthur Hayes stayed the effective date of the pilot program.194

Commissioner Hayes issued the stay in response to a Presidential Mem-orandum requiring agencies in the executive branch to suspend for sixtydays all regulations that were to become effective within a sixty dayperiod.195 The Presidential Memorandum was followed by Executive Or-der 12,291, which required the suspension of major regulations to permitagencies to reconsider their necessity and cost.'9

18 Id. at 60,756.189 Id. at 60,781-82.190 Id. at 60,788-817."144 Fed. Reg. 40,016, 40,024 (1979).192 45 Fed. Reg. 60,754, 60,783 (1980) (codified at 21 C.F.R. § 203.26).193 Kennedy, Remarks of the Commissioner, 32 FoOD DRUG COSM. L.J. 384, 386

(1977).I" Prescription Drug Products That Require Patient Package Inserts; Tem-

porary Stay of Effective Dates, 46 Fed. Reg. 23,739 (1981) (codified at 21 C.F.R.§ 203). The stay did not effect the regulations requiring patient package insertsfor the oral contraceptives or the estrogen drugs.

191 Presidential Memorandum of January 29, 1981, 3 C.F.R. 223 (1981).11 Exec. Order No. 12,291, 3 C.F.R. 127 (1981), reprinted in 5 U.S.C. § 601 at

431-34 (1982).

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4. Revocation of the Program

In September of 1982, the FDA revoked the regulations which wouldhave established the PPI program.19 7 Although the PPI program wasfavored by consumer groups, the FDA withdrew the regulations underpressure from drug manufacturers and medical associations. 198 The pri-

mary reason given by the FDA for its revocation of the PPI program wasthe belief that voluntary programs could accomplish the goal of supplyingpatient information and concern that the PPI program would stifle the

voluntary programs currently underway. 199 Subsequent surveys indicate,however, that patients remain inadequately informed.'0°

V. RATIONALE FOR RE-ENACTING THE PPI PROGRAM

A. Failure of the Voluntary Programs

In revoking the PPI program, the FDA did not revoke its commitmentto providing patient information, nor did it revoke its findings concerningthe effectiveness of written information. 20 1 The FDA revoked the programbecause the agency believed that written patient information could be

supplied more cost effectively via voluntary programs such as that pro-

posed by the American Medical Association (AMA). 20 2

The American Medical Association opposed the PPI program on behalf

of physicians who were concerned about how mandatory PPIs would affect

the physician-patient relationship and who desired discretionary rather

than mandatory distribution. 03 The AMA initiated a voluntary program

,97Prescription Drug Products; Revocation of Patient Package Insert Require-ments, 47 Fed. Reg. 39,147 (1982) (codified at 21 C.F.R. § 203).

198 See Public Citizen v. Dep't of Health and Human Servs., No. 81-0820 (D.D.C.July 31, 1981) (mem.), affd 671 F.2d 518 (D.C. Cir. 1981) (per curium) (PublicCitizen, a consumer group, challenged the FDA stay of the PPI program); Phar-maceutical Mfrs. Ass'n v. FDA, 484 F. Supp. 1179 (D. Del. 1980), affd, 634 F.2d106 (3d Cir. 1980) (drug manufacturers and pharmaceutical groups challengedthe FDA'S authority to require patient package inserts). See also 44 Fed. Reg.40,016, 40,020-21 (1979) (surveys showing consumer support for patient packageinserts); 44 Fed. Reg. 40,016, 40,022-24 (comments against patient labeling andFDA responses); 47 Fed. Reg. 39,147, 39,148 (1982) (stating that physicians,manufacturers and distributors of prescription drugs supported revocation of theregulations while consumers and consumer organizations opposed the revocation).

19 47 Fed. Reg. 39,147, 39,148 (1982).200 See infra notes 205-207 and accompanying text.201 47 Fed. Reg. 39,147, 39,148 (1982). The FDA noted that it has repeatedly

affirmed that patients have both a right and need to know about the drugs theyuse, and that traditionally they have not had adequate information about pre-scription drugs available to them. Id. The agency agreed with comments statingthat only written information adequately informs patients and noted that writteninformation which the patient can retain and refer to later is very useful. Id.

20- Id. at 39,148-49.m Gifford, From PPI to PIL to PMI: Can the Private Sector Do It Better?, 50

CLEv. CLiac Q. 26 (1983).

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PRESCRIPTION DRUGS

to provide Patient Medication Instruction (PMI) sheets to physicians fordistribution to patients. PMIs cost less than one cent each and are avail-able for approximately one hundred frequently prescribed drugs or drugclasses.

20 4

Studies indicate, however, that patients are still inadequately in-formed. In a 1984 survey, only twenty-six percent of the patients sampledwere told about precautions, twenty-three percent were informed aboutside effects and only five percent received written information. 20 5 A 1985survey indicated that seventy-four percent of the patients surveyed werenot informed of side effects,206 and a 1987 survey indicated that four outof five patients were not informed of potential side effects. 20 7

B. Increased Patient Participation

In today's medically conscious society, patients desire to be active par-ticipants, not passive recipients of prescription drug therapy.29 Surveysindicate that patients desire more patient information and are willing topay for it. A nationwide survey indicated that forty-nine percent of therespondents wanted additional information about prescription drugs, par-ticularly written information in nontechnical language to be dispensedwith the prescription drug.20 9 Another survey of television viewers re-ported that sixty-nine percent of noon viewers and fifty-seven percent ofevening viewers were willing to pay an additional thirty cents per pre-scription to receive patient package inserts.210 FDA estimated that patientpackage inserts would cost nine cents per prescription if applied to newand refilled prescriptions and eighteen cents per prescription if appliedonly to new prescriptions.

2 1 '

C. Prescription Drug Advertising

Within the last few years, manufacturers have begun to advertise pre-scription drugs directly to consumers, and television viewers of certain

204 American College of Physicians, Drug Information for Patients, 104 ANNALSOF INTERNAL MED. 121 (1986).

205 Morris, Grossman, Barkdoll, Gordon & Soviero, A Survey of Patient Sourcesof Prescription Drug Information, 74 AM. J. PUB. HEALTH 1161, 1162 (1984) (seetable 2).

216 Gilhooley, Learned Intermediaries, Prescription Drugs, and Patient Infor-mation, 30 ST. Louis U.L.J. 633, 669 (1986) (citing Morris, Grossman, Barkdoll& Gordon, A National Survey of Prescription Drug Information Provided to Pa-tients, table 8 (1986) (copy available at office of St. Louis Univ. Law Journal).

217 Information for Patients About Medicines, 1 LANCET 1077, 1078 (1987).208 McGarey, Pharmaceutical Manufacturers and Consumer-Directed Infor-

mation-Enhancing the Safety of Prescription Drug Use, 34 CATH. U.L. REV. 117,143 (1984).

29 44 Fed. Reg. 40,016, 40,020 (1979).21u 45 Fed. Reg. 60,754, 60,759 (1980).211 Id. at 60,777.

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CLEVELAND STATE LAW REVIEW [Vol. 39:111

cable networks have the opportunity to see advertisements for prescrip-tions drugs which are supposedly aimed at the physician.212 Prescriptiondrug advertising is currently opposed by the FDA which is attemptingto establish guidelines for public advertising of prescription drugs. 213

The advent of prescription drug advertising may be used by some courtsto impose a duty on prescription drug manufacturers to warn consumersdirectly.2 14 Aggressive marketing techniques and advertisements assur-ing women of the safety and efficacy of oral contraceptives were twofactors considered by the courts holding that oral contraceptive manu-facturers have a common law duty to warn consumers directly.21 5 A pre-scription drug manufacturer who advertises a product is voluntarilybypassing the physician as learned intermediary. The goal of advertisingis to create demand for a product and even though the physician is nec-essarily involved in the patient's actual receipt of the prescription drugproduct, the manufacturer has departed from its traditional role of dealingexclusively with the physician. 216 But as noted by the majority opinionin In re Certified Questions,217 an expansion of such a well settled area oflaw is best left to the legislature. 21 8

VI. CONCLUSION

Prompted by the FDA regulations, recent cases have recognized an oralcontraceptive exception to the learned intermediary doctrine, thus im-posing upon manufacturers of oral contraceptives a common law duty towarn patients directly.2 9 The courts in these cases reasoned that oralcontraceptives are an "elective" drug with a relatively high incidence ofsevere adverse reactions.220 It is foreseeable that the courts will extendthis reasoning to other "elective" drugs and gradually to the "non-elec-

212 Rheingold, The Expanding Liability of the Drug Manufacturer to the Con-sumer, 40 FOOD DRUG COM. L.J. 135, 139 (1985). Lifetime, a cable service withan audience of 18.2 million households, has approximately ten hours a week ofphysician programming. Id. at 139 n.18. See also Morris & Millstein, Drug Ad-vertising to Consumers: Effects of Formats for Magazine and Television Adver-tisements, 39 FOOD DRUG CoMs. L.J. 497 (1984); Novitch, Direct-to-ConsumerAdvertising of Prescription Drugs, 39 FOOD DRUG Coms. L.J. 306 (1984).

I's Rheingold, supra note 212, at 139.214 Id. at 141.115 See, e.g., Stephens v. G.D. Searle & Co., 602 F. Supp. 379, 380 (E.D. Mich.

1985); Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867. 875 (E.D. Mich.1985); In re Certified Questions, 419 Mich. 686, 712, 358 N.W.2d 873, 884 (1984)(Boyle, dissenting) (Boyle's opinion was cited by the courts in Stephens and Odg-ers).

216 Rheingold, supra note 212, at 141.217 419 Mich. 686, 358 N.W.2d 873.218Id. at 691-92, 358 N.W.2d at 874.219 See supra notes 113-127 and accompanying text.2120 See supra notes 29, 124 and accompanying text.


PRESCRIPTION DR UGS

tive" drugs.221 The exceptions are likely to engulf the rule, thus imposingupon the prescription drug manufacturers a common law duty to warnpatients directly for all prescription drugs.222 Also, the advent of pre-scription drug advertising, which effectively bypasses the physician aslearned intermediary, may result in the courts' imposing upon prescrip-tion drug manufacturers a common law duty to warn patients directly. 22

3

A common law duty to warn is likely to result in labeling requirementswhich vary from jurisdiction to jurisdiction. 224 Manufacturers could beforced to provide warnings concerning every possible risk, resulting inlengthy warnings which patients are unlikely to read. Administrativeregulation of patient information, such as that proposed by the FDA,could ensure that the consumers receive patient information in a stand-ardized, understandable format.2 25

The regulations should require that prescription drug manufacturerswarn the patient directly where a warning can readily be conveyed inlay person's language. "A manufacturer's failure to warn the consumerdirectly should result in liability for any injury to the consumer proxi-mately caused by use of the drug. '226 On the other hand, some drugspresent potential for adverse effects not easily communicated in lay lan-guage. 227 In such cases the physician should have the duty to warn thepatient.22 1 To avoid conflicting labeling requirements imposed by statelaw, the regulations should specify that patient package inserts meetingthe standards set by the regulations constitute adequate disclosure bylaw. 229 To satisfy the rare instance where non-disclosure is in the patient'sbest interest, the regulations may allow the physician to specify that thepatient package insert be withheld.22 0 Although logic dictates that patientinformation is best utilized by the patient before he leaves the physician's

221 See supra notes 29-34 and accompanying text. See also Flannagan, ProductsLiability: The Continued Viability of the Learned Intermediary Rule as it Appliesto Product Warnings for Prescription Drugs, 20 U. RICHMOND L. REV. 405 (1986);Fern, The Decline and Fall of the Learned Intermediary Doctrine, 28 FOR THEDEFENSE 10 (1986).

222 Id.223See supra notes 212-217 and accompanying text.224 See supra notes 128-129 and accompanying text.225 See supra notes 181-193 and accompanying text.226 Flannagan, supra note 220, at 423.227 Id.228 Id.229 See supra notes 128-29, 223-24 and accompanying text.20 The FDA allowed for certain exemptions from the patient package insert

dispensing requirements. One of the exemptions allowed the prescribing physicianto direct on the prescription in his or her handwriting that the patient packageinsert not be provided to the patient. 45 Fed. Reg. 60,754, 60,783 (1980) (codifiedat 21 C.F.R. § 203.26).

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office, practicality in enforcement of the regulations and time constraintsupon the physician dictate that the pharmacist is the best choice as dis-penser of patient package inserts.23 1

The patient package insert is a workable solution as attested to by thefact that they are still required for oral contraceptives.2 2 There is littledoubt that patients are better informed of the risks associated with the

oral contraceptives than the risks associated with other prescription drugswhich do not require patient package inserts. 232 In today's medically con-scious society, the patient should be regarded as a consumer of a prod-uct.23 As a consumer, the patient should be an active participant in

prescription drug therapy, not a passive recipient of whatever informationthe physician deems best.235

ALAN R. STYLES

2' The FDA noted: 1) that pharmacists traditionally serve as dispensers ofprescription drugs and are best able to collate, store, and provide labeling topatients; 2) that physicians prescribe drugs by telephone and may not have theopportunity to dispense the patient package insert; and 3) that dispenser distri-bution is more appropriate under FDA'S statutory authority for the regulatingand labeling of drug products. 44 Fed. Reg. 40,016, 40,033 (1979). The FDA statedthat it agrees that physicians have primary responsibility for advising patientsabout prescription drugs. Nevertheless, patient labeling is intended to serve pri-marily as an informational adjunct to the patient-physician encounter to reinforceand augment the information given to the patient by the physician. 44 Fed. Reg.40,016, 40,032 (1979). The FDA stated further that although the regulations donot require a physician who is not the dispenser of the drug to provide the patientwith the patient package insert, physicians are encouraged to present and discussthe patient package insert with the patient. Id.

22 47 Fed. Reg. 39,147 (1982) (revoking 45 Fed. Reg. 60,754 (1980) (proposed

patient package insert program), but not 43 Fed Reg. 4214 (1978) (labeling re-quirements for oral contraceptives)).

m A Gallup poll taken before FDA regulations required patient package insertfor oral contraceptives indicated that two-thirds of the women surveyed had notbeen told of the risks associated with the use of oral contraceptives. Kincke, supranote 148, at 625.

-3 McGarey, supra note 208, at 143.23 5

Id.

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Prescription Drugs and the Duty to Warn: An Argument for